K912934
Substantially EquivalentAMS SPHINCTER 800 URINARY PROSTHESIS
- Applicant
- American Medical Systems, Inc.
- Product code
- FAG
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minnetonka, MN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.